CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma
Clinical Study of CD19/CD20 Bispecific Nanobody-derived CAR-T Cells in Refractroy/Relasped B Cell Lymphoma
1 other identifier
interventional
50
1 country
2
Brief Summary
Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2019
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 16, 2019
CompletedFirst Posted
Study publicly available on registry
March 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedMarch 21, 2019
January 1, 2019
2 years
March 16, 2019
March 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
occurrence of study related adverse events
safety of CAR-T cells
one year
Secondary Outcomes (3)
objective response rate
three months
survival time of CAR-T cells in vivo
one year
progression-free survival
one year
Study Arms (1)
experimental arm
EXPERIMENTALCAR-T cell group
Interventions
collecting blood for CAR-T cells culture three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg
Eligibility Criteria
You may qualify if:
- expected lifetime\>3 months
- CD19/CD20 positive relapsed/refractory B cell lymphoma
- KPS\>70
- at least one measurable lesion according to RECIST 1.1
- enough function of hear, liver, kidney and bone marrow
- no history of severe allergies
- no other history of malignancy
- no other diseases that conflict with this regimen
- no serious mental illness
- patient or family member sign informed consent
You may not qualify if:
- Pregnant or lactating women
- Severe infectious or viral disease
- Active B or C viral hepatitis
- Patients who have used large amounts of glucocorticoids or other immunosuppressive agents during the last 4 weeks
- participated in other clinical studies in the last 3 months, or have been treated with other gene products
- Others not appropriate to participate in this study examined by the investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henan Cancer Hospitallead
- Henan Hualong Biotechnology Companycollaborator
Study Sites (2)
Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yongping Song, Dr.
Henan Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2019
First Posted
March 19, 2019
Study Start
February 1, 2019
Primary Completion
January 31, 2021
Study Completion
January 31, 2022
Last Updated
March 21, 2019
Record last verified: 2019-01